Pattern Patient Engagement Platform – Pilot Overview
“Pattern” is a flexible platform bridging gaps between cancer patients and scientists. Pattern effectively matches the cancer patients and the scientists working to advance science towards new discoveries. Pattern is an initiative of The Rare Cancer Research Foundation (RCRF), a 501(c)3 dedicated to curing rare cancers through strategic investments and collaborations that catalyze effective research and accelerate deployment of promising therapies.
1. Pilot Objectives: The goal is to engage patients in cancer research by providing a framework (www.Pattern.org) for patients to donate their excess fresh tumor tissue and medical information in order to develop cell line models with thorough clinical annotation to deepen the understanding of the disease. These tumor samples will be sent to the Broad Institute of MIT and Harvard, to be included as part of the Broad Institute’s research protocol led by Jesse Boehm, Ph.D.: “Generation, Characterization, & Distribution of Cell Line Models of Human Cancer.” Dr. Boehm’s research study, called the Cancer Cell Line Project (CCLP), is focused on developing cell line models to answer important cancer research questions. The cell line models generated will be genomically sequenced and screened against drugs to create a “dependency map,” identifying potential points of therapeutic intervention. The models developed by the Broad Institute will be made available to the research community following accessioning at either the Coriell Institute for Medical Research or another non-profit biorepository.
2. Pilot Scope: RCRF will work with each selected Pilot Foundation (“PF”) to identify, register, and consent ten (10) patients to participate in the project. The selected PF will not incur any costs associated with participating in the pilot. RCRF will assume responsibility for the costs associated with the procurement and transport of the ten (10) sample sets or however many sample sets (to a maximum of 10 sample sets) are procured during a period of six (6) months. The Broad Institute will assume responsibility for the development of the cell lines and the subsequent screening.
3. Pilot Foundation Responsibilities : (Patient referral & tissue donation importance patient education)
a. Actively encourage patients to donate their tumor and medical information to research by registering and providing consent at Pattern.org.
b. Embed a link and language provided by RCRF on the PF’s website to enable patients to seamlessly enroll.
c. Sign a Mutual Non-Disclosure with RCRF.
d. Engage the PF’s patient community using social media, newsletters, general outreach, etc., to raise awareness for the pilot study and the importance of donating tissue for research purposes.
e. Discuss pilot with investigators and notify RCRF of areas of opportunity.
f. Provide ongoing and direct patient feedback and recommendations on Pattern.org use & design.
4. RCRF Responsibilities (Patient registration, Informed Consent collection, Biologistics Process management)
a. Develop and provide to selected PFs and their patient communities access to Pattern.org.
b. Manage patient data, de-identification and the informed consent process.
c. Manage biologistics process to transport up to ten data-annotated fresh tissue samples from the point of resection at a medical center to the Broad Institute.
d. Work with the Broad to support the development of cell line models.
5. Research Protocol: This Pilot study provides support to the Broad Institute’s research protocol titled: “Generation, Characterization, & Distribution of Cell Line Models of Human Cancer” through the use of RCRF’s “Pattern” platform which was approved by the Dana Farber Cancer Institute’s (DFCI) Institutional Review Board (IRB).
6. Tissue Requirements: The absolute minimum amount of tissue needed is 1mm X 3mm. However, larger amounts of tissue are strongly preferred in order to aid in the development of cancer cell lines.
7. Fulfillment: RCRF matches patient samples with research protocols that are using scientific methods for model development. Due to the variable and challenging nature of cell line establishment, RCRF cannot guarantee the establishment of models.
8. Intellectual Property: The goal of this pilot is to generate cell line models which will be widely available in the public domain to drive cancer research. In order to advance this aim, RCRF, The Broad and PFs will not retain any intellectual property with respect to any cell lines generated as part of this pilot study.
Why is Tissue Donation Valuable?
Significant advancements have been made in medical research using both normal and tumor tissue to advance diagnoses, therapies and cures. As the scientific community gets closer to identifying genes responsible for different cancers, tissue donation to benefit research is critical. Tissue samples provide a model to test new ways to determine what may have caused the cancer and to test the effectiveness of new methods of prevention, diagnosis and treatment.
How to Donate Tissue
You can learn more about opportunities to donate tissue at www.Pattern.org, a subsidiary of the Rare Cancer Research Foundation, will link you to specific research projects and empower you to donate your tissues to investigators that are passionate about advancing the science for your cancer. There is no cost for you to participate.
What exactly is tissue?
Cancer tissue collected for staging, diagnosis and research may include include a portion of the tumor, surrounding normal tissue and might also include blood and fluid. During a medical procedure such as an operation, biopsy or blood test, your doctor will remove tissue needed for a complete pathology report. Then, with your consent, any leftover tissue can be sent to a research facility or tissue bank to be used for research.
What effect can donating tissue have on my care?
By donating your tissue to research, you’re giving scientists the opportunity to better understand your cancer and develop treatment for future patients just like you. Although you may not directly benefit from donating your tissue, the research on your tissue may benefit other cancer patients in the future. Research involving the use of your tumor sample and associated data will not affect or alter your current care.
Will my surgeon take more tissue than he/she would otherwise take during the normal course of my cancer surgery?
No. The tissue utilized for research would come from the tissue that has already been extracted and no extra tissue would be removed.
How does Pattern.org work?
Pattern.org enables cancer patients to directly donate their tumor tissue and medical data to research. Once you enroll, Pattern.org will link you to a specific research project studying your cancer. You can then learn about the study and review and sign an informed consent if you wish to contribute. If you choose to contribute, we will arrange the transfer of your cancer tumor on your behalf.
What is an informed consent?
The process by which a patient learns about and understands the purpose, benefits, and potential risks of a medical procedure or research study, and then agrees to receive the treatment or participate in the research. Informed consent generally requires the patient or responsible party to sign a statement confirming that they understand the risks and benefits of the procedure, treatment or research participation.
Will I receive the result of any research done on my tumor?
You will not receive results on any research done on your tumor.
Does donating my tumor affect the surgical procedure?
No. Your physician is already planning to remove your tumor — your donation will not influence in any way how or when your surgery is done. In fact, the tumor samples we receive are excess tissue from your surgery that isn’t needed for your medical care.
How long before surgery do I need to complete the consent?
As early as possible! If you decide a donation is right, we ask you complete the informed consent at least a week before your scheduled date of surgery. This allows us enough time to coordinate the biologistics necessary to ensure successful transfer of your tumor tissue to the designated research project.
How does my doctor know what to do once I complete the forms?
Pattern.org will get in touch with your doctor and surgical institution to provide instructions for what needs to be done.
Is there anything I need to do after I complete the forms on Pattern.org?
No. Your doctor may ask you to confirm your decision when you arrive for surgery. Pattern.org will take care of the rest.
What if my doctor says there isn’t enough tissue to send?
If there is not enough of the tumor to send, that means your tumor was too small or not viable to be used for research.
Is my information protected?
Yes, Pattern.org maintains all collected information on a secure database.
What if I decide I don’t want to participate prior to my donation?
Inform Pattern.org and your surgeon of your decision immediately.
What happens if I decide I don’t want to participate after my donation?
You can visit Pattern.org or contact the number on your informed consent to revoke your consent at any time.